Dietary Modulation of Neuroinflammation in Age-Related Memory Disorders (NCT03723694) | Clinical Trial Compass
CompletedNot Applicable
Dietary Modulation of Neuroinflammation in Age-Related Memory Disorders
United States259 participantsStarted 2019-01-01
Plain-language summary
The purpose of this study is to test the effect of a cocoa-derived dietary flavanol on brain structures and cognitive outcomes in a 12-week randomized controlled trial of 146 healthy participants, age 50-69, who will receive this cocoa derivative or a placebo. Th investigators will also examine the role of inflammation in this relationship.
Who can participate
Age range50 Years – 69 Years
SexALL
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Inclusion criteria
✓. Signed and dated informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal screening or management of the subject).
✓. Healthy Male or Female subjects. (Females must be post-menopausal)
✓. Age between 50 and 69 years, both inclusive.
✓. Body mass index between 18.0 and 35 kg/m², both inclusive.
Exclusion criteria
✕. Currently undergoing medical treatment, including prescription drugs/medication.
✕. Clinically significant abnormal hematology, biochemistry, urinalysis, or coagulation screening tests, as judged by the Investigator.
✕. History or presence of cancer (except basal cell skin cancer or squamous cell skin cancer), or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological (with the exception euthyroid struma), haematological, dermatological, venereal, neurological, psychiatric diseases or other major disorders as judged by the Investigator.
✕. Seated blood pressure at screening (after resting for 5 min in seated position) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic (excluding white-coat hypertension; therefore, if a repeated measurement shows values within the range, the subject can be included in the trial) and/or resting supine heart rate outside the range 50-90 beats per minute. Measurement taken at consent before eligibility is determined